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nameSildenafil Citrate
Impurity 4
Metaxalone
Impurity A
Metaxalone
Impurity B

category

cas_number

mol_formulamol_weightsynonym
3-(4,7-Dihydro-1-methyl-7-oxo-3-propyl-

impurities

C17H20N4O5S

392.43

1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4ethoxybenzenesulfonic Acid

1391053-95-4
impurities

59365-66-1

C11H16O3

196.3

3-(3,5-Dimethylphenoxy)propane-1,2-diol

impurities

108-68-9

C8H10O

122.2

3, 5-Dimethylphenol

impurities

59365-66-1

C11H16O3

196.246

3-(3,5-dimethylphenoxy)propane-1,2-diol

3-(3,5-Dimethyl
Phenoxy )-1,2Propane
Diol(Impurity -A)
N6-Demethylazithromycin;
Azithromycin
Impurity A

impurities

76801-85-9

C37H70N2O12

734.96

Desmethylazithromycin ; 9-Deoxo-9a-aza9a-homo Erythromycin A ; Azaerythromycin
A ; Azathramycin

Azithromycin
Impurity B
Azithromycin
Impurity E

impurities

307974-61-4

C38H72N2O11

732.98

impurities

612069-27-9

C36H68N2O12

720.5

Dexketoprofen Related CompoundA

3-Deoxyazithromycin ; 3-Deshydroxy
Azithromycin ;Amino Azithromycin ; 3′-(N,NDidemethyl)azithromycin ;α-Methyl-3-(4-impurities

107257-20-5

C17H16O3

268.31

methylbenzoyl)benzeneacetic acid, 2-[3(4-Methylbenzoyl)phenyl]propionic acid

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name1,1,3,3 Tetramethyl
butyl amine salt

category

cas_number

mol_formulamol_weightsynonym
PRAVASTATIN 1,1,3,3-TETRAMETHYL

impurities

151006-14-3

C31H55NO7

553.77BUTYLAMINE;Pravastatin 1,1,3,3TetraMethylbutylaMine Salt;
Pioglitazone IMpurity B;Pioglitazone EP

Didehydro
Pioglitazone

impurities

144809-28-9

C19H18N2O3S

354.42282

IMpurity B;Didehydro Pioglitazone
Impurity,5-(4-(2-(5-Ethyl pyridine-2yl)Ethoxy)Benzydiene)-2-4-thiazolidine,

1-Nitroso-I-Proline
CETRIZINE
IMPURITY

impurities

7519-36-0

C5H8N2O3

144.13(2S)-1-nitrosopyrrolidine-2-carboxylic acid
1-(4-Chlorobenzyhydryl)piperazine((RS)-1-

impurities

C17H19ClN2

286.8

942132-30-1[(4-Chlorophenyl)Phenylmethyl]piperazine)
rel-4-[4-[4-[4-[[(2R,4R)-2-(2,4Dichlorophenyl)-2-(1H-1,2,4-triazol-1-

Itraconazole EP
Impurity E

impurities

C35H38C12N8O4 778.85

ylmethyl)-1,3-dioxolan-4yl]methoxy]phenyl]-1-piperazinyl]phenyl]2,4-dihydro-2-(1-methylpropyl)-3H-1,2,4triazol-3-one;

252964-65-1

Azithromycin Noxide

impurities

90503-06-3

C₃₈H₇₂N₂O₁₃

764.98Azithromycin EP Impurity L; Azithromycin
Impurity L / USP RRT - 0.29

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namecategory

cas_number

mol_formulamol_weightsynonymsodium;(6R,7S)-7-[[2-Cefmetazole Na
Impurity(cyanomethylsulfanyl)acetyl]amino]-7impurities

C15H16N7NaO5S3 493.51yl)sulfanylmethyl]-8-oxo-5-thia-156796-39-5

Albendazole
Sulfoxide

methoxy-3-[(1-methyltetrazol-5-

impurities

54029-12-8

azabicyclo[4.2.0]oct-2-ene-2-carboxylate
C12H15N3O3S

281.33methyl N-(6-propylsulfinyl-1Hbenzimidazol-2-yl)carbamate
tert-butyl 2-[4-[[4-methyl-6-(1-Telmisartan t-Butyl
Ester

impurities

C37H38N4O2

570.72144702-26-1
EsZopiclone NOxide Impurity

impurities

151851-70-6

methylbenzimidazol-2-yl)-2propylbenzimidazol-1yl]methyl]phenyl]benzoate

C₁₇H₁₇ClN₆O₄

404.81(S)-(+)-Zopiclone N-Oxide;
4’-[(1,4’-Dimethyl-2’-propyl[2,6’-bi-1H-

Telmisartan Amide

impurities

C₃₃H₃₁N₅O

513.63915124-86-6
Zolpidem-6Carboxylic Acid
R(-) Sitagliptin
Mandalate Acid

benzimidazol]-1’-yl)methyl][1,1’-biphenyl]2-carboxamide;
3-[2-(Dimethylamino)-2-oxoethyl]-2-(4-impurities

C17H16N2O2

280.32109461-15-6
impurities

486460-00-8

methylphenyl)imidazo[1,2-a]pyridine-6carboxylic Acid; SL 84.0853;

C₈H₈O₃152.15(αR)-α-Hydroxybenzeneacetic Acid; DMandelic Acid; (-)-(R)-Mandelic Acid;

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nameLisinopril EP
Impurity A
Lisinopril EP
Impurity C
Lisinopril EP
Impurity D
Lisinopril Dihydrate
Impurity G

category

cas_number

mol_formulamol_weightsynonymDL-2-Amino-4-phenylbutyric Acid; 2-

impurities

C10H13NO2

179.221012-05-1

Amino-4-phenylbutyric Acid; 2-Amino-4phenylbutanoic Acid;(S)-2-((3S,8aS)-3-(4-aminobutyl)-1,4-

impurities

C21H29N3O4

387.47328385-86-0

dioxohexahydropyrrolo[1,2-a]pyrazin2(1H)-yl)-4-phenylbutanoic acid(2S)-2-((3S)-3-(4-aminobutyl)-1,4-

impurities

C21H29N3O4

387.47219677-82-4
impurities

83915-83-7

dioxohexahydropyrrolo[1,2-a]pyrazin2(1H)-yl)-4-phenylbutanoic acid

C21H35N3O7

441.52

Lisinopril dihydrate impurity
G;HLRMNXJOFRUYAM-NGTAMTFRSA-N;(1S)-1-[3-(Dimethylamino)propyl]-1-(4-Lisinopril Dihydrate

impurities

C21H35N3O7

441.52583915-83-7

fluorophenyl)-1,3-dihydro-5isobenzofurancarbonitrile Ethanedioate;(Z)-2-((((2-Amino-4-thiazolyl)(((2S,3S)-2-

DesulfatedAztreonam

impurities

C13H17N5O5S

355.369102579-59-9Open Ring
Aztreonam

methyl-4-oxo-3azetidinyl)carbamoyl(methylene)amino(oxy)-2-methylpropionic acid;(2S,3S)-3-amino-2-[[(2Z)-2-(2-amino-1,3-

impurities

C13H19N5O6S
87500-74-1

373.384

thiazol-4-yl)-2-(2-carboxypropan-2yloxyimino)acetyl]amino]butanoic acid

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nameBisoprolol Ester
CompoundBisoprolol
Benzylalcohol
Lacosamide Chiral
Impurity
DiPhenyl Analog of
oxybutynin
Ethyl Propyl Analog
of Oxybutynin

category
impurities

cas_number
864544-37-6

mol_formulamol_weight

C18H29NO5

339.432

impurities

C26H40N205

460.6115258-73-8
impurities
impurities

175481-37-5
14943-53-4

impurities

C13H18N2O3

250.3

C22H25NO3.HCl

387.19

C23H33NO3.HCl

407.19impurities

C13H12N4O2

256

260435-42-5

Trazole Indole 3
Acetic Acid(S)-2-(Acetylamino)-3-methoxy-N(phenylmethyl)propanamide;4-(Diethylamino)but-2-ynyl 2-Hydroxy-2,2diphenylacetate ;4-(Ethylpropylamino)but-2-ynyl (RS)-2cyclohexyl-2-hydroxy-2-phenylacetate HCltriazol-1-ylmethyl)-1H-indol-3yl]ethanamine
Hydroxy-4-[4-(hydroxydiphenylmethyl)-1-

impurities

C32H39NO4

501.65479035-75-1

Compound-B
Impurity G

isopropylaminopropoxy)benzyloxylmethyl]benzoic acid;N,N-dimethyl-2-[5-(1,2,4-

Fexofenadine

Fluvoxamine(propan-2-ylamino)propoxy]benzoate

phenoxy]-3-isopropylaminopropan-2-ol ;1215677-72-7

Impurity
Related2-propan-2-yloxyethyl 4-[2-hydroxy-3(RS)-1-[4-[4-(2-Hydroxy-3-

Rizatriptan
Carboxylic Acid

synonym

impurities
impurities

192876-02-1
177270-91-6

piperidinyl]butyl]-α,α- Acid
Hydrochloride;

C14H19F3N2O2

304.31

C₁₃H₁₂N₄O

256.265E)-5-[(2-Aminoethoxy)imino]-5-[4(trifluoromethyl)-phenyl]pentan-1-ol ;5-(1H-1,2,4-Triazol-1-ylmethyl)-1H-indole3-acetic Acid;

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namecategory

cas_number

mol_formulamol_weightsynonym
3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-

Risperidone NOxide

impurities

C23H27FN4O3

426.21832747-55-41-oxido-1-piperidinyl]ethyl]-6,7,8,9tetrahydro-2-methyl-4H-pyrido[1,2a]pyrimidin-4-one ;1-​Pentanone, 1-​[4-​(difluoromethyl)​phenyl]​Fluvoxamine
Impurity E

C15H21F3N2O2.

impurities

C4H4O4-​5-​methoxy-​, O-​(2-​aminoethyl)​oxime; 2434.41

methoxypentylidene]amino]oxy]ethanamine;1217214-94-2
Ibuprofen ImpurityA
Ibuprofen ImpurityD
Ibuprofen ImpurityE

impurities
impurities
impurities

66622-47-7
938-94-3
38861-78-8[[[(1E)-1-[4-(Difluoromethyl)phenyl]-5-

C13H18O2

206.28(2RS)-2-(3-isobutylphenyl)propanoic acid

C10H12O2

164.2(2RS)-2-(p-tolyl)propanoic acid

C12H16O

176.251-(4-isobutylphenyl)ethan-1-one
4-(1-Hydroxy-2-methylpropyl)-α-Ibuprofen ImpurityL

impurities

C₁₃H₁₈O₃

222.2853949-53-4
Ibuprofen ImpurityM

impurities

1262894-13-2

methylbenzeneacetic Acid;2-[4’-(1Hydroxy-2-methylpropyl)phenyl]propionicAcid;

C13H18O3

222.28(2RS)-2-hydroxy-2-(4isobutylphenyl)propanoic acid

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namecategory

cas_number

mol_formulamol_weightsynonymα-Methyl-4-(2-methyl-1-

Ibuprofen ImpurityJ

impurities

C₁₃H₁₆O₃

220.2665813-55-0

oxopropyl)benzeneacetic Acid;2-(4Isobutyrylphenyl)propionic Acid; Ibuprofen
Impurity J;
N2-[(1S)-1-Carboxy-3-cyclohexylpropyl]-

Lisinopril
Cyclohexyl Analog

L-lysyl-L-proline; (2S)-1-[(2S)-6-Amino-2impurities

C21H37N3O5

411.53cyclohexylpropyl]amino]hexanoyl]pyrrole1132650-67-9

Pregabalin Impurity-I
Pregabalin Impurity-II
Pregabalin Impurity-III
Pregabalin Impurity-IV
Rizatriptan -NOxide[[(1S)-1-carboxy-3-

impurities
impurities
impurities
impurities

1568181-40-7
1136478-30-2
216576-74-8
75143-89-4

impurities
260435-42-5

2-carboxylic Acid;
C9H17NO3

187.24

C9H16O4

188.22

C8H15NO

141.21

C8H17NO2

159.23

C15H19N5O

285.34Pregabalin Amide Impurity ; (S)-3(aminomethyl)-5-methylhexanamide
5,6-Dehydro Pregabalin ; 3-(aminomethyl)5-methylhex-5-enoic acid
4,5-Dehydro Pregabalin Formate ; 3(aminomethyl)-5-methylhex-4-enoic acid
Pregabalin Impurity B (3-Isobutylglutaric
Acid) ; 3-isobutylpentanedioic acidN,N-dimethyl-2-[5-(1,2,4-triazol-1ylmethyl)-1H-indol-3-yl]ethanamine oxide

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namecategory

cas_number

mol_formulamol_weightsynonym
7-Chloro-1,6,7,8-tetradeoxy-6-[[[(2S,4R)-

Clindamycin
Sulfoxide

1-methyl-4-propyl-2impurities

C₁₈H₃₃ClN₂O₆S

440.98(methylsulfinyl)-L-threo-α-D22431-46-5

Fluvoxamine
Impurity Oxime

galactooctopyranose;(NE)-N-[5-methoxy-1-[4-impurities

C13H16F3NO2

275.2788699-84-7

1-​Pentanone, 5-​hydroxy-​1-​[4-​
impurities

Impurity A
Repaglinide
Impurity B
Repaglinide
Impurity C
Repaglinide
Impurity D

C14H19F3N2O2

304.31

192876-02-1

Malonamide
Repaglinide(trifluoromethyl)phenyl]pentylidene]hydrox
ylamineFluvoxamine
Impurity G

pyrrolidinyl]carbonyl]amino]-1-

impurities
impurities

220438-80-2
99469-99-5(trifluoromethyl)​phenyl]​-​, O-​(2-​aminoethyl)​oxime, (1E)​-;

C₁₁H₁₂O₅

224.21

C13H16O5

252.264-Carboxy-3-ethoxybenzeneacetic Acid;[3-Ethoxy-4-(ethoxycarbonyl)phenyl]acetic
acid ;(αS)-α-(2-Methylpropyl)-2-(1-impurities

C₂₃H₃₇N₃O₅

435.56219921-94-5

piperidinyl)benzenemethanamine NAcetyl-L-glutamate;
Ethyl 2-ethoxy-4-[2-[[(1S)-3-methyl-1-[2-impurities

C29H40N2O4147770-06-7

480.64(piperidin-1-yl)phenyl] butyl] amino]-2oxoethyl]benzoate ;VIVAN社総販売店： オー・ジー株式会社
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nameArmodafinil
Impurity A
Armodafinil
Impurity B
Armodafinil
Impurity C
Eslicarbamazepine
Impurity A
24-EPI-Calcipotriol(MC900-000)

category

cas_number

mol_formulamol_weightsynonym
Benzyhydrylsulfinylacetic

impurities

C15H14O3S

274.33NA
impurities

Benzhydrylsulphinylacetic acid;
C15H14O2S

258.34

C15H15NO3S

289.35

C15H12N2O

236.27

C27H40O3

412.6047

63547-22-8
impurities
impurities
impurities

118779-53-6
236395-14-5
112827-99-3acid;(Benzhydrylsulfinyl)acetic acid;2-

BENZHYDRYLSULFANYL ACETIC ACID;2PHENYL METHYLTHIO ACETIC ACID;
2-[(Diphenyl methyl)sulfonyl] acetamide
5H-Dibenz[b,f]azepine-5-carboxamide; 5Carbamoyl-5H-dibenz[b,f]azepine;
Calcipotriol EP Impurity D;24R-Calcipotriol;(1S,3S,5E)-5-[(2E)-2-[(1R,3aS,7aR)-1[(1R,2E,4S)-4-Cyclopropyl-4-hydroxy-1-

5,6 trans Calcipotriol

impurities

C₂₇H₄₀O₃

412.6

methyl-2-buten-1-yl]octahydro-7a-methyl4H-inden-4-ylidene]ethylidene]-4methylene-1,3-cyclohexanediol; 5,6-trans-

557-48-2
Voriconazole-Noxide

Calcipotriol;(αR,βS)-α-(2,4-Difluorophenyl)-5-

impurities

C16H14F3N5O2618109-05-0

365.31fluoro-β-methyl-α-(1H-1,2,4-triazol-1ylmethyl)-1-oxide-4-pyrimidineethanol;

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namecategory

cas_number

mol_formulamol_weightsynonym4-[(4-methylpiperazin-1-yl)methyl]-N-(4-Imatinib Impurity

impurities

C25H25N5O4S

491.56404844-03-7
Salmeterol Impurity
A
Salmeterol ImpurityB

impurities

methyl-3-{[4-(pyridin-3-yl)pyrimidin-2yl]amino}phenyl)benzamide;

C20H25NO4

343.4231798014-51-3[1-[4-hydroxy-3-(hydroxymethyl)phenyl]2-(4-phenylbutylamino)ethyl] formate
1-[4-Hydroxy-3-(hydroxymethyl)phenyl]-

impurities

C23H33NO4

387.5194749-02-7

2-[[6-(2-phenylethoxy)hexyl]amino]
ethanol ;4-[1-hydroxy-2-[2-(hydroxymethyl)-4-[1-Salmeterol Impurity
D

impurities

C34H47NO7

581.751391052-04-2
Esomeprazole
Impurity A
Esomeprazole
Impurity B

Esomeprazole
Impurity D

impurities

37052-78-1

hydroxy-2-[6-(4phenylbutoxy)hexylamino]ethyl]phenoxy]ethyl]-2-(hydroxymethyl)phenol

C17H19N3O4S

361.42Omeprazole EP Impurity A ; 5-Methoxy1H-benzimidazole-2-thiol ;2-[[(3,5-Dimethyl-2-

impurities

C17H19N3O4S

361.42110374-16-8

pyridinyl)methyl]sulfinyl]-6-methoxy-1Hbenzimidazole;
Esomeprazole USP Related Compound A ;impurities

C17H19N3O3S
88546-55-8

345.42Omeprazole EP Impurity D ;Esomeprazole
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nameSalmeterol Impurity
F
Bosentan Impurity
A

category

cas_number

mol_formulamol_weightsynonym(R)-4-(1-hydroxy-2-((6-(4-impurities

C25H37NO3

399.571391054-40-2

phenylbutoxy)hexyl)amino)ethyl)-2methylphenol
4-(tert-butyl)-N-(6-chloro-5-(2-impurities

C25H24ClN5O4S 526.01
150727-06-3

methoxyphenoxy)-[2,2'-bipyrimidin]-4yl)benzenesulfonamide
O-Deshydroxyethyl Bosentan ; 4-(tert-

Bosentan ImpurityB

impurities

C25H25N5O5S

507.56butyl)-N-(5-(2-methoxyphenoxy)-6-oxo3,6-dihydro-[2,2'-bipyrimidin]-4yl)benzenesulfonamide

174227-14-6

N,N'-((ethane-1,2-diylbis(oxy))bis(5-(2Bosentan ImpurityC

impurities

C52H52N10O10S2 1041.16

D
Bosentan ImpurityEdiyl))bis(4-(tertbutyl)benzenesulfonamide)

1097263-60-9
Bosentan Impurity

methoxyphenoxy)-[2,2'-bipyrimidine]-6,4-

4-tert-butyl-N-[5-(2-methoxyphenoxy)-4impurities

C25H25N5O5S

507.565

174227-14-6
impurities

6292-59-7

oxo-2-pyrimidin-2-yl-1H-pyrimidin-6yl]benzenesulfonamide

C10H15NO2S

213.3

4-(tert-Butyl)benzenesulfonamide

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namecategory

cas_number

mol_formulamol_weightsynonym
Voriconazole Triazole Acetophenone

Voriconazole
Impurity A

Impurity (USP) ; Voriconazole USP RC C ;impurities

C16H14F3N5O

349.31

Fluconazole EP Impurity E ; 1-(2,4Difluorophenyl)-2-(1H-1,2,4-triazol-1-

86404-63-9yl)ethanone ;Voriconazole USP Related Compound D ;Voriconazole
Impurity B

impurities

C16H15F2N5O

331.32

182369-73-9

Desfluoro Voriconazole ; (2RS,3SR)-2-(2,4Difluorophenyl)-3-pyrimidin-4-yl-1-(1H1,2,4-triazol-1-yl)butan-2-ol ;Voriconazole USP RC B ; epi-Voriconazole

Voriconazole
impurity D; Voriconazole (2S,3R)-Enantiomer ;impurities

C16H15F2N5O

331.32pyrimidin-4-yl-1-(1H-1,2,4-triazol-1137234-63-0yl)butan-2-ol ;5-chloro
Hydrochlorothiazid

5,6-Dichloro-3,4-dihydro-2H-1,2,4impurities

Impurity B

C7H7Cl2N3O4S2 332.18
5233-42-1eClopidogrel(2S,3R)-2-(2,4-Difluorophenyl)-3-

benzothiadiazine-7-sulfonamide 1,1Dioxide;
Methyl (+/-)-(o-Chlorophenyl)-4,5-

impurities

C16H16ClNO2S.H2 419.9
144750-52-7

SO4

dihydrothieno[3,2-c]pyridine-6(7H)acetate
Hydrochloride;VIVAN社総販売店： オー・ジー株式会社
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namecategory

cas_number

mol_formulamol_weightsynonym
Clopidogrel USP Related Compound C ;Clopidogrel
Impurity C

Clopidogrel Bisulfate R-Isomer ; Methyl (impurities

C16H16ClNO2S.H2 419.9
SO4

dihydrothieno[3,2-c]pyridine-5(4H)-

120202-71-3
Levodopa Impurity
D

impurities

5796-17-8yl]acetate hydrogen sulfate ;C9H11NO4

197.19Aminoquat(Colsevelam)-(R)-(o-chlorophenyl)[6,7-(R)-2-amino-3-(3,4dihydroxyphenyl)propanoic acid ; D-Dopa
1-​Hexanaminium, 6-​amino-​N,​N,​N-​

impurities

Impurity)

C9H23BrN2

239.2

trimethyl-​, bromide, hydrobromide; (6Aminohexyl)trimethylammonium bromide,

33968-67-1

Decyl Aminoquat(Colsevelam

impurities

C
Gabapentine
Impurity E
Voriconazole
Impurity C

379.46NA

Impurity)
Levodopa Impurity

C19H43BrN2

6-(decylamino)-N,N,N-trimethylhexan-1aminium bromide hydrobromide
Levodopa USP Related Compound B ;impurities

C10H13NO4

211.217636-26-2
impurities

667465-00-1(2RS)-2-Amino-3-(4-hydroxy-3methoxyphenyl)propanoic acid ;C9H14O4186.2

1-(carboxymethyl)cyclohexanecarboxylic
acid
Voriconazole Ethylfluoropyrimidine

impurities

C6H7FN2137234-88-9

126.13

Impurity (USP) ; 4-Ethyl-5-fluoropyrimidine;

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nameVoriconazole
impurity F
4-Trifluromethyl
salicyclic acidcategory
impurities
impurities

cas_number
5872-08-2
328-90-5mol_formulamol_weight

C10H16F2O4S

232.3

C₈H₅F₃O₃

206.12synonym(±)-β-Camphorsulfonic acid, (±)Camphor-10-sulfonic acid
2-Hydroxy-4-(trifluoromethyl)benzoic
Acid; α,α,α-Trifluoro-2,4-cresotic Acid;
Cyclo[L-alanyl-D-alanyl-N-methyl-L-

Cyclosporin
Impurity B

leucyl-N-methyl-L-leucyl-N-methyl-Limpurities

C61H109N11O12 1188.58

6-octenoyl-L-alanyl-N-methylglycyl-Nmethyl-L-leucyl-L-valyl-N-methyl-L-leucyl63775-95-1
Cyclosporin
Impurity C

valyl-3-hydroxy-N,4-dimethyl-L-2-amino-

Thr2-cyclosporine;7-Limpurities

C62H111N11O13 1218.61
59787-61-0

Threoninecyclosporin A;7-LThreoninecyclosporin A,(2S)-2-Methylbutanoic Acid

Simvastatin
impurity E(1S,3R,7S,8S,8aR)-1,2,3,7,8,8a-Hexahydroimpurities

C24H36O5

404.543,7-dimethyl-8-[2-[(2R,4R)-tetrahydro-4hydroxy-6-oxo-2H-pyran-2-yl]ethyl]-1-

75330-75-5

naphthalenyl Ester;VIVAN社総販売店： オー・ジー株式会社
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namecategory

cas_number

mol_formulamol_weightsynonym(1S,3R,7S,8S,8aR)-8-[2-[(2R,4R)-4-

Simvastatin
Impurity F

Hydroxy-6-oxotetrahydro-2H-pyran-2impurities

C24H36O5

404.54yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8ahexahydronaphthalen-1-yl (2R)-2-

79952-44-6

methylbutanoate(3R,5R)-((2R,4R)-2-(2-((1S,2S,6R,8S)-8(2,2-Dimethylbutanoyloxy)-2,6-dimethyl1,2,6,7,8,8a-hexahydronaphthalen-1-

Simvastatin
Impurity D

impurities

C50H76O10

837.13yl)ethyl)-6-oxo-tetrahydro-2H-pyran-4-yl)
7-((2S,6R,8S)-8-(2,2dimethylbutanoyloxy)-2,6-dimethyl1,2,6,7,8,8a-hexahydronaphthalen-1-yl)-

476305-24-5

3,5-dihydroxyheptanoate ;[1S-[1α,3α,7β,8β(2S*,4S*),8aβ]]-

Simvastatin
Impurity G

2,2,3-Trimethyl-3-butenoic Acid
impurities

C25H36O5

416.55(tetrahydro-4-hydroxy-6-oxo-2H-pyran-21449248-72-9

Diclofenac Impurity
D

1,2,3,7,8,8a-Hexahydro-3,7-dimethyl-8-[2yl)ethyl]-1-naphthalenyl Ester;
Diclofenac EP Impurity D ; 2-[2-[(2-impurities

C14H11BrClNO2 340.59
127792-45-4

Bromo-6-chlorophenyl) amino]phenyl]
acetic acid

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nameDiclofenac Impurity
E
Diclofenac Impurity
B

category

cas_number

mol_formulamol_weightsynonym
Diclofenac EP Impurity E;2-Oxindole ;2-

impurities

C8H7NO

133.1459-48-3
impurities

22121-58-0

Indolone;1,3-Dihydro-2H-indol-2-one;2Oxindole;2-Indolone.;CS-P-00400

C13H9Cl2NO

266.13

Diclofenac EP Impurity B ; 2-[(2,6Dichlorophenyl)amino]benzaldehyde
Diclofenac Impurity C;Diclofenac alcohol

Diclofenac ImpurityC;2-[(2,6impurities

C13H11Cl2NO

268.14[2-[(2,627204-57-5

Piribedil Catechol

Dichlorophenyl)amino]benzenemethanol;

impurities

50602-50-1

Dichlorophenyl)amino]phenyl]methanol;
C15H18N4O2

286.331-(3,4-DIHYDROXYBENZYL)-4-(2PYRIMIDINYL)-PIPERAZINEM
2-[4-(1,3-BENZODIOXOL-5-

P- Oh Piribedil

impurities

C15H18N4O

270.333605-01-4
Piribedil N- oxide

impurities

53954-71-5

YLMETHYL)PIPERAZIN-1-YL]-5HYDROXY

C16H18N4O3

314.342-[4-(1,3-benzodioxol-5-ylmethyl)-4oxido-1-piperazinyl]-Pyrimidine;7-[(4aS,7aS)-1,2,3,4,4a,5,7,7a-

Moxifloxacin

impurities

C21H24FN3O4
151096-09-2

401.438octahydropyrrolo[3,4-b]pyridin-6-yl]-1cyclopropyl-6-fluoro-8-methoxy-4oxoquinoline-3-carboxylic acid

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namecategory

cas_number

mol_formulamol_weightsynonym(1r,4s)-4-(5-chloro-2-oxo-2,3-dihydro-1H-

Domperidone
Impurity C

impurities

118435-03-3

C22H24ClN5O3

441.91

1,3- benzodiazol-1-yl)-1-[3-(2-oxo-2,3dihydro-1H-1,3- benzodiazol-1yl)propyl]piperidin-1-ium-1-olate.
5-Chloro-3-[3-(2,3-dihydro-2-oxo-1H-

Domperidone
Impurity D

benzimidazol-1-yl)propyl]-1-[1-[3-(2,3impurities

1614255-34-3

C32H34ClN7O3

600.11dihydro-2-oxo-1H-benzimidazol-1yl)propyl]-4-piperidinyl]-1,3-dihydro-2Hbenzimidazol-2-one;

Piroxicam Impurity
L
Zopiclone Impurity
B
Celecoxib Regio
isomer4-Hydroxy-2-methyl-2H-1,2impurities

118854-48-1

C13H15NO5S

297.33benzothiazine-3-carboxylic Acid 1Methylethyl Ester1,1-Dioxide7RS)-6-(5-Chloropyridin-2-yl)-7-hydroxy-

impurities

43200-81-3

C11H7ClN4O2

262.65

6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5one ;Celecoxib EP Impurity B (Celecoxib regio

impurities

331943-04-5

C17H14F3N3O2S 381.37

Isomer,N-De(4-sulfonamidophenyl)-N’-(4sulfonamidophenyl) Celecoxib

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cas_number

mol_formulamol_weightsynonym
2,2-Dimethylbutanoic Acid

Simvastatin
Impurity B(1S,3R,7S,8S,8aR)-8-[2-[(2R,4R)-4impurities

145576-25-6

C₂₇H₄₀O₆

460.6(Acetyloxy)tetrahydro-6-oxo-2H-pyran-2yl]ethyl]-1,2,3,7,8,8a-hexahydro-3,7dimethyl-1-naphthalenyl Ester;
2,2-Dimethylbutanoic Acid

Simvastatin
Impurity C(1S,3R,7S,8S,8aR)-8-[2-[(2R)-3,6-Dihydroimpurities

210980-68-0

C25H36O4'400.556-oxo-2H-pyran-2-yl]ethyl]-1,2,3,7,8,8ahexahydro-3,7-dimethyl-1-naphthalenyl
Ester;(3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-4[(2,6-dideoxy-3-C-methyl-3-O-methyl-αL-ribo-hexo pyranosyl)oxy]-14-ethyl-

Roxithromycin
Impurity A

impurities

114-07-8

C37H67NO13

733.93

7,12,13-trihydroxy-3,5,7,9,11,13hexamethyl-6-[[3,4,6-trideoxy-3(dimethylamino)-β-Dxylohexopyranosyl]oxy]
oxacyclotetradecane-2,10-dione;

Diclofenac ImpurityA

1-(2,6-Dichlorophenyl)-1,3-dihydro-2Himpurities

15362-40-0

C14H9Cl2NO

278.13indol-2-one, N-(2,6-Dichlorophenyl)-2indolinone, NSC 621845

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namecategory

cas_number

mol_formulamol_weightsynonym
Levodopa USP Related Compound B ;Levodopa EP
Impurity C

impurities

7636-26-2

C10H13NO4

211.22(2RS)-2-Amino-3-(4-hydroxy-3methoxyphenyl)propanoic acid ; 3-MethylDL-Dopa ;Palonsetron noxide(3aS)-2,3,3a,4,5,6-Hexahydro-2-[(3S)-1impurities

813425-83-1

C₁₉H₂₄N₂O₂

312.41oxido-1-azabicyclo[2.2.2]oct-3-yl]-1Hbenz[de]isoquinolin-1-one,(2R,3S)-2-(2,4-difluorophenyl)-3-(5-Voriconazole oxide

impurities

C16H14F3N5O2

365.316

fluoro-1-oxidopyrimidin-1-ium-4-yl)-1(1,2,4-triazol-1-yl)butan-2-ol

618109-05-0

8 [5-amino-2-(4amino-1,3dioxoisoindolin-2yl)-5-oxopentanoic(γS)-4-Amino-γ-(aminocarbonyl)-1,3impurities

C₁₃H₁₅N₃O₄

277.28Acid;acid]/Pomalidomide Impurity
Didehydro
pioglitazone
Paliperidone
Impurity 1
Paliperidone
Impurity 2

dihydro-1-oxo-2H-isoindole-2-butanoic

2635-64-5

impurities

354.42

C14H15F2NO2

267.27

1-Acetyl-4-(2,4-difluorobenzoyl)Piperidine

C12H14F2N2O

240.254-(2,4-Difluorobenzoyl)piperidine Oxime

144809-28-9

impurities
impuritiesNANA

5-{4-[2-(5-Ethyl-2-pyridinyl) ethoxy]

C19H18N2O3S

benzylidene}-2,4-thiazolidinedione

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namePaliperidone
Impurity 3

category
impurities

cas_numberNAmol_formulamol_weight

C12H14ClF2NO

261.69synonym4-(2,4-Difluorobenzoyl)-piperidinehydrochloride
N-[2-Chloro-6-methylphenyl]-2-[[6-[4-(2-Dasatinib N oxide

impurities

C₂₂H₂₆ClN₇O₃S

504

910297-52-8hydroxyethyl)-1-piperazinyl]-2-methyl-4pyrimidinyl]amino]-5-thiazolecarboxamide
N-Oxide;3-[3-({[(7S)-3,4dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-

Ivabradine N Oxide

impurities

C₂₇H₃₆N₂O₆

484.58yl]methyl}(methyl)amino) propyl]-7,8dimethoxy-2,3,4,5-tetrahydro-1H-3-

NA
Ciprofloxacin
chloro analog
Prasugrel Impurity
3

benzazepin-2-one N-Oxide
6-Chloro-1-cyclopropyl-1,4-dihydro-4-

impurities

C₁₇H₁₈ClN₃O₃'347.80

93106-58-2

quinolinecarboxylic Acid5-(1-(2-fluorophenyl)-2-oxopropyl)-

impurities

C20H21BrFNO3 S 454.35
951380-42-0

iperazine

4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl
acetate1-(4Chlorobenzhydryl)poxo-7-(1-piperazinyl)-3-(RS)-1-[(4impurities

C17H19ClN2
303-26-4

286.8

Chlorophenyl)phenylmethyl]piperazine,
NSC 86164, Norchlorcyclizine;

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cas_number

mol_formulamol_weightsynonym(2R,3R,4S,5R)-5-(4-BENZAMIDO-2-

Sofosbuvir impurity

impurities

C20H17FO6

372.34

1233335-78-8
Sofosbuvir- 7 2'beta- fluoro

impuritiesOXOPYRIMIDIN-1(2H)-YL)-2((BENZOYLOXY)METHYL)-4-FLUORO-4METHYLTETRAHYDROFURAN-3-YL

C₂₈H₆₁FN₅O₁₄P₃

803.73

1987957-28-7(2’R)​-2’-​Deoxy-​2’-​fluoro-​2’-​methyl-uridine
5’-​Triphosphate Triethylammonium Salt;(-)-trans-Diltiazem; (2R,3S)-5-[2-Diltiazem EP
Impurity A

impurities

C22H26N2O4S

414.52

Diltiazem Impurity

Diclofenac Impurity C;Diclofenac alcohol
impurities

C21H25ClN2O4S 436.95
142926-07-6

Diltiazem

desacetyl Diltiazem
HCl;2-[(2,6Dichlorophenyl)amino]benzenemethanol;

Diltiazem Impurity
G/N-Desmethyl

methoxyphenyl)-4-oxo-2,3,4,5-tetrahydro1,5-benzothiazepin-3-yl acetate

103532-27-0
C / O-desmethyl(dimethylamino)ethyl]-2-(4-(2S,3S)-5-[2-(Methylamino)ethyl]-2-(4impurities

C19H22N2O3S.HCl 394.91
86408-44-8

methoxyphenyl)-4-oxo-2,3,4,5-tetrahydro1,5-benzothiazepin-3-ol

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cas_number

mol_formulamol_weight

Diltiazem Impurity
H/N,N,OTridemethylsynonym(2S,3S)-5-(2-Aminoethyl)-3-hydroxy-2-(4-impurities

C17H18N2O3S'330.40hydroxyphenyl)-2,3-dihydro-1, 5benzothiazepine-4(5H)-onedesacetyl diltiazem

115992-91-1 (base)
2-[(2-Aminoethoxy)methyl]-4-(2-Amlodipine

impurities

C₂₀H₂₅ClN₂O₅

408.8888150-42-9

chlorophenyl)-3-ethoxycarbonyl-5methoxycarbonyl)-6-methyl-1,4dihydropyridine;
3-ethyl 5-methyl 4-(2-chlorophenyl)-2-

Amlodipine
Impurity

impurities

C25H34ClNO6

480.0188150-62-3
Tizanidine Nacetyl((2-(1,3-dioxoisoindolin-2yl)ethoxy)methyl)-6-methyl-1,4dihydropyridine-3,5-dicarboxylate
1-[2-[(5-Chloro-2,1,3-benzothiadiazol-4-

impurities

C₁₁H₁₀ClN₅OS

295.75173532-15-5yl)amino]-4,5-dihydro-1H-imidazol-1-yl]ethanone;
4-[4-[[[[4-Chloro-3-

Sorafenib N oxide

impurities

C21H16ClF3N4O4 480.82
583840-03-3

Abiraterone Chloro
impurity

impurities

NA(trifluoromethyl)phenyl]amino]carbonyl]am
ino]phenoxy]-N-methyl-2pyridinecarboxamide 1-Oxide;

C21H30O3

330.473-β-Acetoxy-5-androsten-17-one,
Prasterone acetate

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namecategory

cas_number

mol_formulamol_weight(2R,3R,6S)-N,6-Bis(4-Ezetimibe
Tetrahydropyransynonym

impurities

Analog Impurity

C24H21F2NO3

409.441296129-15-1

fluorophenyl)tetrahydro-2-(4hydroxyphenyl)-2H-pyran-3-carboxamide;
SCH59566

1H-Indole-7carboxamide,5[(2R)-2-[[2-(2ethoxyphenoxy)ethyl]amino]propyl]-1-

1H-Indole-7-carboxamide,5-[(2R)-2-[[2impurities

C₂₅H₃₅N₃O₄

441.56(2-ethoxyphenoxy)ethyl]amino]propyl]-1(3-hydroxypropyl)-,monohydrochloride(3-hydroxypropyl),monohydrochloride/Ethoxy Silodosin

Tenegliptin
sulfoxide239463-74-2[(2S,4S)-4-[4-(3-Methyl-1-phenyl-1Himpurities

C₂₂H₃₀N₆O₂S

442.583-thiazolidinylmethanone Sulfoxide;

NA
Emtricitabine
sulfoxidepyrazol-5-yl)-1-piperazinyl]-2-pyrrolidinyl]-

4-Amino-5-fluoro-1-[(2R,5S)-2impurities

C8H10FN3O4S
152128-77-3

263.35(hydroxymethyl)-3-oxido-1,3-oxathiolan-5yl]-2-(1H)-pyrimidone ;VIVAN社総販売店： オー・ジー株式会社
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nameLamotrigine 3 3
dimer

category

cas_number

mol_formulamol_weight3-[[5-Amino-6-(2,3-dichlorophenyl)-1,2,4impurities

C19H14Cl4N10524.19dimer
Ropinirole ImpurityCtriazine-3-amino]methylamino]-5-amino6-(2,3-dichlorophenyl)-1,2,4-triazine;

1797983-48-2
Lamotrigine 5 5synonymN5,N5'-Methylenebis(6-(2,3impurities

C19H14Cl4N10524.19N/A
impurities

221264-43-3

dichlorophenyl)-1,2,4-triazine-3,5-diamine); Lamotrigine Dimer Impurity 2

C10H11NO'161.20

4-Ethyl-1,3-dihydro-2H-indol-2-one10-(2,4,5-Trifluorobenzyl)-3-

Sitagliptin
Triazecine Analog

impurities

C₁₆H₁₃F₆N₅O₂

421.3

NA

(trifluoromethyl)-6,7,10,11-tetrahydro[1,2,4]triazolo[3,4-c][1,4,7]triazecine8,12(5H,9H)-dione(E)-(+/-)-7-[3-(4-Fluorophenyl)-1-5-oxo Fluvastatin

impurities

C₂₄H₂₄FNO₄

409.451160169-39-0
Memantine
Impurity IV
2-Hydroxymethyl
Olanzapine(methylethyl)-1H-indol-2-yl]-3-hydroxy-5oxo-6-heptenoic Acid;
1-Amino-7-hydroxy-3,5-

impurities

C12H21NO'195.30

63971-25-5

dimethyladamantane; 3-Amino-​5,​7-​
dimethyl-tricyclo[3.3.1.1(3,​7)]​decan-​1-​ol[4-(4-methylpiperazin-1-yl)-5H-

impurities

C17H20N4OS
174756-45-7

328.43thieno[3,2-c][1,5]benzodiazepin-2yl]methanol

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name27-O-Desmethyl
Sirolimus
41-O-Desmethyl
Sirolimus

category
impurities
impurities

cas_number
N/A
151519-50-5

mol_formulamol_weightsynonym

C50H77NO13

900.1727-O-Desmethyl Rapamycin

C₅₀H₇₇NO₁₃

900.15

7-O-Demethyl Cypher; 7-O-Demethyl
Rapammune;
3R,5S,6E)-7-[4-(4-Fluorophenyl)-6-(1-ROSUVASTATINMETHYL ESTER

methylethyl)-2impurities

C23H30FN3O6S

495.56[methyl(methylsulfonyl)amino]-5pyrimidinyl]-3,5-dihydroxy-6-heptenoic

147118-40-9

Acid Methyl Ester;(3R,5S,6E)-7-[4-(4-Fluorophenyl)-6-(1-ROSUVASTATINISOAMYL ESTER

methylethyl)-2impurities

C27H38FN3O6S

551.67

pyrimidinyl]-3,5-dihydroxy-6-heptenoic
1197348-98-3

Betahistine
Impurity B
Betahistine
Impurity A[methyl(methylsulfonyl)amino]-5-

impurities
impurities

103-74-2
100-69-6

Acid 3-Methylbutyl Ester;
C7H9NO

123.15

C7H7N

105.142-(2-Hydroxyethyl)pyridine, 2-(2Pyridyl)ethanol
2-Vinylpyridine(R)-1-(3-hydroxypropyl)-5-(2-((2-(2-SILODOSIN
IMPURITY MD309

impurities

C25H30F3N3O4
175870-21-0

493.52(2,2,2trifluoroethoxy)phenoxy)ethyl)amino)propyl)-1H-indole-7-carboxamide

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namecategory

cas_number

mol_formulamol_weight

2,6-Dimethyl-4-(3-nitrophenyl)-3,5-

LERCANIDIPINEHYDROCHLORIDE

impurities

IMPURITY D
Nimesulide
Impurity C
Nimesulide
Impurity D
Escitalopram oxo
Impurity
Ambrisentan
Impurity B

synonym

C36H39N3O6.HCl 646.19
887769-34-8

impurities

pyridinedicarboxylic Acid 3-[2-[(3,3Diphenylpropyl)methylamino]-1,1dimethylethyl] 5-Methyl Ester

C12H11NO

185.222-Aminophenyl phenyl ether

2688-84-8

2-Amino-5-nitrodiphenyl ether, 4-Nitro-2impurities

C12H10N2O3

230.225422-92-4

phenoxyaniline, 4-Nitro-2phenoxybenzenamine
1-[3-(Dimethylamino)propyl]-1-(4-impurities

C20H19FN2O2

338.37372941-54-3

fluorophenyl)-1,3-dihydro-3-oxo-5isobenzofurancarbonitrile;(S)-2-(1-carboxy-2-methoxy-2,2-

impurities

C22H22N2O5

394.4

1106685-84-0

diphenylethoxy)-4,6-dimethylpyrimidine 1oxide;
4-(4-Fluorophenyl)-6-(1-methylethyl)-

ATORVASTATINLACTONEN,2-diphenyl-5-[2-(tetrahydro-4-hydroxyimpurities

C₃₃H₃₃FN₂O₆

572.62

DIEPOXIDE

azatricyclo[4.1.0.02,4]heptane-11046118-40-4

Ropinirole ImpurityD

6-oxo-2H-pyran-2-yl)ethyl]-3,7-dioxa-5-

impurities

173990-76-6

carboxamide;
C16H24N2O4

308.372-(2-(2-(Dipropylamino)ethyl)-6nitrophenyl)-acetic acid hydrochlorideVIVAN社総販売店： オー・ジー株式会社
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nameDiclofenac
epolamine

category

cas_number

mol_formulamol_weightsynonym2-[(2,6-Dichlorophenyl)amino]-

impurities

C₂₀H₂₄Cl₂N₂O₃

411.32119623-66-4

benzeneacetic Acid compound with 1Pyrrolidineethanol;

Mesalamin
Impurity A – 4Aminophenol R

impurities

C6H7NO

109.134-Aminophenol, 4-Hydroxyaniline

C6H7NO

109.134-amino 2-hydroxybenzoic acid

C6H7NO

109.13C7H7NO2

137.14123-30-8(EP)
Mesalamin
Impurity B – 3Aminophenol R

impurities
591-27-5(EP)
Mesalamin
Impurity C – 2Aminophenol R

impurities

5-amino-2-hydroxy-3-(4sulfophenyl)benzoic acid95-55-6(EP)
Mesalamin
Impurity D – 3Aminobenzoic acid(EP)

impurities
99-05-8

3-Amino benzoic acid; 3-aminobenzoic
acid

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namecategory

cas_number

mol_formulamol_weightsynonym

Mesalamin
Impurity F – 3Aminosalicylic acid

impurities

C7H7NO3

153.14C7H6O4154.123-Amino-2-hydroxybenzoic acid570-23-0(DMF)
Mesalamin
Impurity G –2,5dihydroxybenzoic

impurities

EP Impurity F

Hydroquinonecarboxylic acid490-79-9acid (EP)
Sulfamethoxazole

2,5-DHBA, DHB, Gentisic acid,

4-Amino-N-(3-methyl-5impurities

C₁₀H₁₁N₃O₃S

253.2817103-52-5

isoxazolyl)benzenesulfonamide; 5Sulfanilamido-3-methylisoxazole;

Mesalamin
Impurity K –Aniline

impurities

C6H7N

93.13

62-53-3(EP)

3R,5S,7S,8R,9S,10S,13R,14S,17R)-17-

Ursodeoxycholicacid

impurities

alcohol(impurity-I)

C₂₄H₄₂O₃

378.59130593-75-8(impurity-G)((R)-5-Hydroxypentan-2-yl)-10,13dimethylhexadecahydro-1Hcyclopenta[a]phenanthrene-3,7-diol;

Ursodeoxycholicacid methyl ester

Aniline HCl, PhenylamineHydrochlorid(3α,5β,7β)-3,7-Dihydroxycholan-24-oic
impurities

C₂₅H₄₂O₄
10538-55-3

406.6

Acid Methyl Ester; 3α,7β-Dihydroxy-5βcholanic Acid Methyl Ester;VIVAN社総販売店： オー・ジー株式会社
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name
LEVETIRACETAMCYCLIC ACID
4-Chloro amide
Levetiracetam
Tavaborole
Impurity A
Tavaborole
Impurity B

category
impurities
impurities

cas_number
67118-31-4
102767-31-7

mol_formulamol_weight

C8H13NO3'171.20

C₈H₁₅ClN₂O₂

206.67synonym2RS)-2-(2-Oxopyrrolidin-1-yl)butanoicacidS)-N-[1-(Aminocarbonyl)propyl]-4chlorobutanamide
5-fluoro-1,2-dihydro-1-hydroxy-2-[(4-impurities

C11H13BFNO5

269.03NA
impurities

2357-33-7

methylphenyl)sulfonyl]-2,3,1benzodiazaborine

C7H7FO2

142.135-fluoro-1,2-dihydro-1-hydroxy-2,3,1benzodiazoborine(βR,δR)-2,3-Βis(4-fluorophenyl)-β,δ-Tavaborole
Impurity C

impurities

C7H6BFO2

151.93

NA
Tavaborole
Impurity D
Cinacalcet
Impurity C
Acyclovir ImpurityG

impurities

174671-88-6

dihydroxy-5-(1-methylethyl)-4[(phenylamino)carbonyl]-1H-pyrrole-1heptanoic Αcid Calcium Salt;

C₇H₆BFO₂

151.934-Fluoro-1,3-dihydro-1-hydroxy-2,1benzoxaborole(R,E)-N-(1-(Naphthalen-1-yl)ethyl)-3-(3-impurities

C22H21ClF3N

391.86955373-56-5(trifluoromethyl) phenyl)prop-2-en-1amine HCl ;Acyclovir N,O-Diacetate ; 2-[[2-impurities

C12H15N5O575128-73-3

309.28(Acetylamino)-6-oxo-1,6-dihydro-9Hpurin-9-yl]methoxy]ethyl acetate

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namecategory

cas_number

mol_formulamol_weightsynonym2-amino-9-((2-((2-amino-6-oxo-1,6-Acyclovir Impurity I

impurities

C14H16N10O4

388.34

1797832-75-7
Acyclovir Impurity
O
Acyclovir ImpurityNdihydro-7H-purin-7yl)methoxy)ethoxy)methyl)-1,9-dihydro6H-purin-6-one
2-Amino-1,7-dihydro-7-[(2-impurities

C9H13N5O4'255.23NA
impuritieshydroxyethoxy)methyl]-6H-purin-6-one;
N7-[(2-Hydroxyethoxy)methyl)guanine;

C13H17N5O6'339.30

N/A(2-((2-acetamido-6-oxo-1,6-dihydro-9Hpurin-9-yl)methoxy)ethoxy)methyl acetate
9,9'-((ethane-1,2-Acyclovir Impurity J

impurities

C14H16N10O4

388.35166762-90-9diylbis(oxy))bis(methylene))bis(2-amino1,9-dihydro-6H-purin-6-one)(4R,6R)-6-[2-[2-(4-Fluorophenyl)-5-(1-Atorvastatin
Impurity I

methylethyl)-3-phenyl-4impurities

C40H47FN2O5

654.81[(phenylamino)carbonyl]-1H-pyrrol-1yl]ethyl]-2,2-dimethyl-1,3-dioxane-4-

125971-95-1

acetic Acid 1,1-Dimethylethyl Ester
Enalaprilic Acid Dihydrate; (2S)-1-[(2S)-2-

Enalapril maleate
Impurity C

impurities

C18H28N2O784680-54-6

384.42[[(1S)-1-Carboxy-3phenylpropyl]amino]propanoyl]pyrrolidine2-carboxylic Acid Dihydrate;

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nameEnalapril maleate
Impurity D
Enalapril maleate
Impurity E
Enalapril maleate
Impurity F

category

cas_number

mol_formulamol_weightsynonymaS,3S,8aS)-Hexahydro-3-methyl-1,4-

impurities

C20H26N2O4

358.43115729-52-7

NA
impuritiesa]pyrazine-2(1H)-acetic Acid Ethyl Ester;
C26H32N2O5.

impurities

C4H4O4
C22H32N2O5.

76391-34-9

dioxo-a-(2-phenylethyl)pyrrolo[[]1,2-

C4H4O4(S)-1-[[]N-[[]3-Phenyl-1568.61[[](phenylethoxy)carbonyl]propyl]-Lalanyl]-L-proline;

404.51 116.07((S)-1-butoxy-1-oxo-4-phenylbutan-2-yl)L-alanyl-L-proline(2S)-1-[(2S)-2-[[(1R)-1-(Ethoxycarbonyl)-

Enalapril maleate
Impurity A

C20H28N2O5.

impurities

C4H4O4376.45 116.07

1356932-13-2

3phenylpropyl]amino]propanoyl]pyrrolidine2-carboxylic Acid; (S,S,R) Enalapril;(+)-N-[[]1-(S)-Ethoxycarbonxyl-3-

Enalapril maleate
Impurity B

impurities

C15H21NO4

279.33

1

1-Carboxyethyl]amino]benzenebutanoic
Acid;82717-96-2
Lapatinib Impurity

phenylpropyl]-L-alanine; (aS)-a-[[][[](1S)-

2-chloro-4-((6-(5-(((2impurities

C22H21ClN4O4S 472.95
1268997-70-1(methylsulfonyl)ethyl)amino)methyl)furan2-yl)quinazolin-4-yl)amino)phenol

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cas_number

mol_formulamol_weightsynonym6-(4-((3-chloro-4-((3-Lapatinib Impurity
2

impurities

C29H24ClFN4O4S 579.04

fluorobenzyl)oxy)phenyl)amino)quinazolin6-yl)-1-(2-(methylsulfonyl)ethyl)pyridin-1ium-3-olate

1807733-95-4

6-[5-(aminomethyl)furan-2-yl]-N-[3Lapatinib Impurity
3

impurities

C26H20ClFN4O2 474.91
697299-82-4

Lapatinib Impurity
5
Metformin Impurity
A
Metformin Impurity
B
Metformin Impurity
C
Metformin Impurity
Dchloro-4-[(3fluorophenyl)methoxy]phenyl]quinazolin-4amine
5-(4-((3-chloro-4-((3-impurities

C26H17ClFN3O4 489.89
231278-84-5

impurities
impurities
impurities
impurities

461-58-5
2959-04-8
1985-46-2
108-78-1

fluorobenzyl)oxy)phenyl)amino)quinazolin6-yl)furan-2-carboxylic acid

C2H4N484.08

C4H8N8168.16

C5H10N6

154.17C3H6N6126.12

Metformin USP RC A ; 1-Cyanoguanidine ;Guanylmelamine HCl ; (4,6-Diamino-1,3,5triazin-2-yl)guanidine HCl ;Metformin USP RC C ; N,N-Dimethyl1,3,5-triazine-2,4,6-triamine ;Melamine ; 1,3,5-Triazine-2,4,6-triamine ;VIVAN社総販売店： オー・ジー株式会社
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nameMetformin Impurity
E
Metformin Impurity
F
Valsartan Related
Compound A
Valsartan Related
Compound B
Valsartan Related
Compound C
Atorvastatin
Impurity A

category

cas_number

mol_formulamol_weightsynonym
Metformin USP RC B ; N-Desmethyl

impurities

C3H11N5O4S

213.2236801-25-9
impurities

506-59-2

Metformin Sulfate ; 1-Methyl Biguanide
Sulfate ;C4H12N6

144.18Dimethylamine HCl ;N-(1-Oxopentyl)-N-[[2’-(2H-tetrazol-5-

impurities

C24H29N5O3

435.52137862-87-4yl)[1,1’-biphenyl]-4-yl]methyl]-D-valine;
CGP 49309;
N-(1-Oxobutyl)-N-[[2’-(2H-tetrazol-5-

impurities'C23H27N5O3

421.49952652-79-8yl)[1,1’-biphenyl]-4-yl]methyl]-L-valine;
Valsartan Imp. C (EP).;
N-(1-Oxopentyl)-N-[[2’-(2H-tetrazol-5-

impurities

C31H35N5O3

525.64137863-20-8yl)[1,1’-biphenyl]-4-yl]methyl]-L-valine
Phenylmethyl Ester;
Atorvastatin EP Impurity A (Sodium Salt) ;impurities

C33H35N2NaO5

562.63433289-84-0

Atorvastatin USP Related Compound A ;Desfluoro Atorvastatin Sodium ;(βR,δR)-2,3-Bis(4-fluorophenyl)-β,δ-Atorvastatin
Impurity C

impurities

C33H33F2N2NaO5 598.61
693794-20-6

dihydroxy-5-(1-methylethyl)-4[(phenylamino)carbonyl]-1H-pyrrole-1heptanoic acid hemicalcium salt

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namecategory

cas_number

mol_formulamol_weightsynonym(βR,δR)-2-(4-Fluorophenyl)-β,δ-Atorvastatin
Impurity B

impurities

C33H34Ca0.5FN2O 577.67
887196-25-0

Ketone Impurity ofEzetimibe
N-Methyl Etodolac

5

dihydroxy-5-(1-methylethyl)-3-phenyl-4[(phenylamino)carbonyl]-1H-pyrrole-1heptanoic acid hemicalcium salt
(3R,4S)-1-(4-Fluorophenyl)-3-[3-(4-impurities

C₂₄H₁₉F₂NO₃

407.41

191330-56-0
impurities

849630-94-0

fluorophenyl)-3-oxopropyl]-4-(4hydroxyphenyl)-2-azetidinone

C₁₈H₂₃NO₃

301.381,8-Diethyl-1,3,4,9-tetrahydro-9methylpyrano[3,4]indole-1-acetic Acid;
2,3-Dihydro-1-(3-hydroxypropyl)-5-[(2R)-

Benzyl silodosin

impurities

C₂₅H₃₂F₃N₃O₄

495.53160970-54-7
Ornidazole ImpurityA

2-[[2-[2-(2,2,2trifluoroethoxy)phenoxy]ethyl]amino]propyl]-1H-indole-7-carboxamide;
α-(Chloromethyl)-2-methyl-4-nitro-

impurities

C7H8ClN3O2

201.61

imidazole-1-ethanol; 1-(3-Chloro-2hydroxypropyl)-2-methyl-4-nitroimidazole;

1384752-15-1(3R,6E)-7-[4-(4-Fluorophenyl)-6-(1methylethyl)-2Rosuvastatin EP-C

impurities

C22H26FN3O6S

479.52[methyl(methylsulfonyl)amino]-5pyrimidinyl]-3-hydroxy-5-oxo-6-heptenoic

1422619-13-3

Acid;

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cas_number

mol_formulamol_weightsynonym(3S,5R,6E)-7-[4-(4-Fluorophenyl)-6-(1-Rosuvastatin EP-G

impurities

C22H28FN3O6S 481.54
1242184-42-4

methylethyl)-2-[methyl (methyl sulfonyl)
amino]-5-pyrimidinyl]-3,5-dihydroxy-6heptenoic acid calcium salt ;(3R,5R,6E)-7-[4-(4-Fluorophenyl)-6-(1-Rosuvastatin(3R,5R)-Isomer

impurities

C22H27FN3O6S

480.531094100-06-7
Riluzole Impurity B

impurities

144631-82-3

methylethyl)-2-[methyl (methyl sulfonyl)
amino]-5-pyrimidinyl]-3,5-dihydroxy-6heptenoic acid calcium salt ;C8H4BrF3N2OS

313.1

C16H15N3O3

297.31

C14H11N3O

237.262

C17H16ClIO2

414.67

4-Bromo-6-(trifluoromethoxy-2benzothiazolamine

Methyl-5(6) [αhydroxybenzyl]
benzimidazole

impurities

2-amino-5(6)impurities
52329-60-9

ole
Empagliflozin
Impurity I
Empagliflozin
Impurity II

benzimidazole-2-carbamate

60254-95-7

carbamatebenzoylbenzimidaz

Methyl 5-[(RS)-α-hydroxybenzyl]-1H-

impurities

915095-94-2(2-amino-3H-benzimidazol-5-yl)phenylmethanone
3-(4-(2-chloro-5iodobenzyl)phenoxy)tetrahydrofuran(R)-(2-chloro-5-iodophenyl)(4-

impurities

C17H14ClIO3
915095-87-3

428.65((tetrahydrofuran-3yl)oxy)phenyl)methanone

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cas_number

mol_formulamol_weightsynonym(1S)-1,5-Anhydro-1-C-[4-chloro-3-[[4-Empagliflozin
Impurity III

impurities

C23H27ClO7

450.92

N/A[[(3R)-tetrahydro-3furanyl]oxy]phenyl]methyl]phenyl]-Dglucitol;
Empagliflozin Impurity 4;(3R,4S,5S,6R)-2-

Empagliflozin
Impurity IV

impurities

C24H29ClO8

480.95

Impurity V
Empagliflozin
Impurity VI
Empagliflozin
Impurity VII
2-Hydroxymethyl
Rilpivirine
Memantine
Acetamido impurity

impurities
impurities
impurities

864070-37-1
1620758-34-0
864070-37-1yl)oxy)benzyl)phenyl)-6-(hydroxymethyl)2-methoxytetrahydro-2H-pyran-3,4,5-triol.

N/A
Empagliflozin(4-chloro-3-(4-(((S)-tetrahydrofuran-3-

C19H21ClNO6

380.83

C25H29ClO8

492.96

C17H16BrClO2

367.67(1S)-1,5-Anhydro-1-C-[4-chloro-3-[(4hydroxyphenyl)methyl]phenyl]-D-glucitol;(S)-3-(4-(5-Bromo-2chlorobenzyl)phenoxy)tetrahydrofuran
2,2'-[(4-impurities

C22H18N6O

382.421798429-64-7
impurities

H-benzimidazole);
C14H23NO

19982-07-1

Methoxyphenyl)carbonohydrazonoyl]bis(1'221.34

1-Actamido-3,5-dimethyladmantane

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cas_number

mol_formulamol_weightsynonym2-[(2-Aminoethoxy)methyl]-4-(2-Amlodipine EP
Impurity A

C20H23ClN2O5

impurities

406

88150-62-3

chlorophenyl)-6-methyl-3,5pyridinedicarboxylic Acid 3-Ethyl 5-Methyl
Ester
3-Ethyl 5-methyl 4-(2-chlorophenyl)-6-

Amlodipine EP
Impurity B

methyl-2-[[2- [[2impurities

C29H32ClN3O7 ; 570.03

methyl]-1,4- dihydropyridine-3,5721958-72-1

Amlodipine Methyl
Ester(methylcarbamoyl)benzoyl]amino]ethoxy]
dicarboxylate ;3,5-Pyridinedicarboxylic acid, 2-[(2-impurities

C25H31ClN2O9

538.98aminoethoxy)methyl]-4-(2-chlorophenyl)1,4-dihydro-6-methyl-, 5-methyl ester ;N/A

3-Ethyl 5-methyl 2-[(2Amlodipine
Impurity D

impurities

C20H23ClN2O5

406.86113994-41-5
Memantine Bromo
Impurity

aminoethoxy)methyl]-4-(2- chlorophenyl)6-methylpyridine-3,5-dicarboxylate oxalate
salt ;
1-Bromo-3,5-dimethyl-

impurities

C12H19Br
941-37-7

243.18

tricyclo[3.3.1.13,7]decane; 1-Bromo-3,5dimethyladamantane;

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namecategory

cas_number

mol_formulamol_weightsynonym

Atorvastatin Epoxy

1b-(4-Fluorophenyl)hexahydro-β,7-Pyrrolooxazin 7-

dihydroxy-7-(1-methylethyl)-1a-phenyl-7a-hydroxy Analog

impurities

C33H34FN2NaO7 612.62(Atorvastatin FX1oxireno[3,4]pyrrolo[2,1-b][1,3]oxazine-31315629-79-8

Impurity
4-(trifluoromethyl)3-nitrobenzoic acid[(phenylamino)carbonyl]-3Hbutanoic acid sodium salt ;3-Nitro-4-trifluoromethylbenzoic acid; 4-

impurities

C8H4F3NO4

235.12(Trifluoromethyl)-3-nitrobenzoic acid;
Benzoic acid,3-nitro-4-(trifluoromethyl)-;

116965-16-3

4-{6-(4-Fluorophenyl)-7,8-epoxy-6Atorvastatin FXA
Impurityhydroxy-8a-isopropyl-7-phenyl-8impurities

C33H34FN2NaO7

612.62pyrrolo[2,1-b][1,3]oxazin-2-yl}-31316291-19-6

Betahistine
Impurity C
Gemcitabine
Impurity C(phenylcarbamoyl)hexahydro-2H -impurities

5452-87-9hydroxybutanoic acid sodium salt ;C15H19N3

241.33

N-Methyl-2-(pyridin-2-yl)-N-[2-(pyridin2-yl)ethyl]ethanamine HCl ;2’-Deoxy-2’,2’-difluorouridine; 2’,2’-

impurities

C₉H₁₀F₂N₂O₅
114248-23-6

264.18

Difluorodeoxyuridine; Gemcitabine
Impurity C (EP);VIVAN社総販売店： オー・ジー株式会社
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namecategory

cas_number

mol_formulamol_weight

2,6-Dimethyl
aniline/Lidocaine
Related Compound

2,6-Dimethylaniline, 2,6-Xylidine, 2impurities

Impurity A
Miconazole Nitrate
Impurity B

C8H12ClN

157.64(1RS)-1-(2,4-Dichlorophenyl)-2-(1Himpurities

C11 H10 Cl2 N2 O 256.017
24155-42-8

impurities

C18H15Cl3N2O .
N/A

impurities

HNO3

381.69Prasugrel hydroxy
thiolactone

C₂₃H₃₀O₆

402.4852-21-1

Impurity C)
impurities

C18H18FNO3S

347.4

947502-66-1

Impurity A
2 chloro tritanol

dichlorophenyl)ethyl]1H-Imidazole(11β)-21-(Acetyloxy)-11,17dihydroxypregna-1,4-diene-3,20-dione;

oxoethyl]-5,6,7,7a-tetrahydro-7ahydroxythieno[3,2-c]pyridin-2(4H)-one;
1-Cyclopropyl-2-(2-fluorophenyl)ethan-

impurities

C11H9FO2

192.181391054-37-7

Diketone
Gliclazide EP

1-[2-[(3-Chlorophenyl)methoxy]-2-(2,4-5-[2-Cyclopropyl-1-(2-fluorophenyl)-2-

Cyclopropyl 2Fluorophenyl

imidazol-1-yl)ethanol ; Tioconazole Imp. D(EP) ;

Prednisolone
Acetate (EpAmino-1,3-dimethylbenzene, 2-Amino-mxylene

87-62-7A
Miconazole Nitratesynonym

impurities
impurities

70-55-366774-02-5

1,2-dione; 2-Fluorophenyl Cyclopropyl
Diketone;

C7H9NO2S

171.22

4-Methylbenzenesulfonamide ;C19 H15 Cl O

294.0811

2-Chloro-2-methylpentane

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nameBenzylated
ezetimibe
Amiodarone
Impurity A
Amiodarone
Impurity B
Amiodarone
Impurity C
Amiodarone
Impurity F
Amiodarone
Impurity G
Chlororanilin
Impurity P
BUDESONIDE
IMPURITY A

category

cas_number

mol_formulamol_weightsynonym(3R,4S)-1-(4-Fluorophenyl)-3-[(3S)-3-(4-impurities

C31H27F2NO3

499.56163222-32-0
impurities

23551-25-9

fluorophenyl)-3-hydroxypropyl]-4-[4(phenylmethoxy)phenyl]-2-azetidinone ;C₂₅H₃₁NO₃

393.52(2-Butyl-3-benzofuranyl)[4-[2(diethylamino)ethoxy]phenyl]methanone;
2-Butyl-3-benzofuranyl-4-[2-impurities

C₂₃H₂₆ClI₂NO₃

653.7296027-74-6(ethylamino)ethoxy]-3,5-diiodophenyl
Ketone Hydrochloride;(2-Butyl-3-benzofuranyl)[4-[2-impurities

C₂₅H₃₀INO₃

519.4285642-08-6
impurities

147030-50-0(diethylamino)ethoxy]-3iodophenyl]methanone;

C₁₉H₁₇IO₃

420.24(2-Butyl-3-benzofuranyl)(4-hydroxy-3iodophenyl)methanone; L 6424;[4-[2-(Diethylamino)ethoxy]-3,5-

impurities

C₂₆H₃₁I₂NO₄

675.341087223-70-8
impurities

106-47-8

impurities
13951-70-7

diiodophenyl][2-(1-methoxybutyl)-3benzofuranyl]methanone;

C6H6ClN

127.57

C₂₁H₂₈O₆

376.444-Chloroaniline, 4-Chloro-1aminobenzene(11β,16α)-11,16,17,21Tetrahydroxypregna-1,4-diene-3,20-dione;

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name
BUDESONIDE
IMPURITY D

category

cas_number

mol_formulamol_weight(11β,16α)-16,17-[Butylidenebis(oxy)]impurities

C₂₅H₃₂O₆

428.52

IMPURITY F(11β,16α)-11,21-Dihydroxy-16,17-[(1impurities

C₂₄H₃₂O₆

416.51

IMPURITY K
Gliclazide EP
Impurity A
Levodopa EP
Impurity A
Levodopa EP
Impurity B
Enzalutamide
Impurity(11β,16α)-21-(Acetyloxy)-16,17impurities

C₂₇H₃₆O₇

472.5751333-05-2
impurities
impurities
impurities

70-55-327244-64-0
60-18-4

Impurity B[butylidenebis(oxy)]-11-hydroxy-pregna1,4-diene-3,20-dione;

C7H9NO2S

171.22

C₉H₁₁NO₅

213.19C₉H₁₁NO₃

181.194-Methylbenzenesulfonamide
2,4,5-Trihydroxy-L-phenylalanine; 2,4,5Trihydroxyphenylalanine;(-)-α-Amino-p-hydroxyhydrocinnamic
Acid; Therigon; p-Tyrosine;
4-[3-[4-Cyano-3-(trifluoromethyl)phenyl]-

impurities

C₂₁H₁₆F₄N₄O₃

448.375,5-dimethyl-2,4-dioxo-1-imidazolidinyl]-2fluoro-N-methylbenzamide;

1443331-78-9
Guaifenesin

methylethylidene)bis(oxy)]pregna-1,4diene-3,20-dione;

638-94-8

BUDESONIDE

11-hydroxy-3,20-dioxopregna-1,4-dien-21al;

85234-63-5

BUDESONIDE

synonym3-(o-Methoxyphenoxy)-1,2-propanediol,
impurities

C₁₀H₁₄O₄
14007-09-1

198.22

Guaiacol Glyceryl Ether, Robitussin,
Guaifenesin Impurity B,

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namecategory

cas_number

mol_formulamol_weightsynonym

7 [5-amino-4-(4amino-1,3dioxoisoindolin-2yl)-5-oxopentanoic(γS)-4-Amino-γ-(aminocarbonyl)-1,3impurities

C₁₃H₁₅N₃O₄

277.28Acid;acid]/Pomalidomid874760-72-2

e Impurity
Levothyroxine
Impurity A

O-(4-Hydroxy-3-iodophenyl)-3,5-diiodo-Limpurities

C₁₅H₁₂I₃NO₄

650.976893-02-3

tyrosine; Liothyronine; T3; L-T3;3,3’,5Triiodothyronine;
1-Chloroacetylamino-2,6-

LIDOCAINERELATEDdihydro-1-oxo-2H-isoindole-2-butanoic

impurities

COMPOUND H

C₁₀H₁₂ClNO

197.661131-01-7

dimethylbenzene, 2-Chloro-2′,6′acetoxylidide, 2-Chloro-2′,6′dimethylacetanilide,
10-Desmethoxycolchiside;(S)-7-amino-

THIOCOLCHICOSIDE EP IMPURITY

1,2-dimethoxy-3-(((2S,3R,4S,5S,6R)-3,4,5impurities

C26H31NO10

517.53H

2H-pyran-2-yl)oxy)-6,7dihydrobenzo[[]a]heptalen-9(5H)-one;

120511-72-0
Hydroxychloroquin
e Impurity B

trihydroxy-6-(hydroxymethyl)tetrahydro-

2-((4-((7-Chloroquinolin-4impurities

103152-84-7

C18H26ClN3O4S 415.93yl)amino)pentyl)(ethyl)amino)ethylhydrogen sulfate;

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nameBenzydamine
Impurity B

category

cas_number

mol_formulamol_weightsynonym

impurities

N/A

C26H29N3O

399.545-Benzyl Benzydamine(3,4α,8α,9β,11α,13α,14β,16β,17Z)-

Diethanolamine
Fusidate

impurities

16391-75-6

C₃₁H₄₈O₆C₄H₁₁NO₂ 516.7110514

16-(Acetyloxy)-3,11-dihydroxy-29nordammara-17(20),24-dien-21-oic Acid
compd. with 2,2’-Iminobis[ethanol];

Alosetron HCl
Impurity
Benzydamine
Impurity C

2,3,4,5-Tetrahydro-5-methyl-2-[(4impurities

128486-89-5

C17H18N4O2

310.35methyl-1H-imidazol-5-yl)methyl]-1Hpyrido[4,3-b]indol-1-one Hydrochloride;
1,2-Dihydro-1-(phenylmethyl)-3H-indazol-

impurities

2215-63-6

C₁₄H₁₂N₂O

224.26

3-one; 1-Benzyl-1,2-dihydro-3H-indazol-3one;
BAY-r 3964, M1-Ciprofloxacin, 7-[(2-Ciprofloxacin
Impurity C

impurities

103222-12-4

C15H17ClFN3O3'341.77

Aminoethyl)amino]-1-cyclopropyl-6-fluoro1,4-dihydro-4-oxo-3-quinolinecarboxylic
Acid;

Ketoprofen
Impurity A

impurities

66067-44-5

C15H12O2'224.26

1-(3-Benzoylphenyl)ethanone; 3Benzoylacetophenone;
2-[(2-Aminoethoxy)methyl]-4-(2-Amlodipine EP
Impurity F Maleate

impurities

140171-66-0

C₁₉H₂₃ClN₂O₅

394.85chlorophenyl)-1,4-dihydro-6-methyl-3,5pyridinedicarboxylic Acid 3,5-dimethyl
Ester;

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mol_formulamol_weightsynonym2-[(2-Aminoethoxy)methyl]-4-(2-Amlodipine EP
Impurity D HCl

impurities

113994-41-5(free base)

C20H23ClN2O5

406.86

chlorophenyl)-6-methyl-3,5pyridinedicarboxylic Acid 3-Ethyl 5-Methyl
Ester Oxalate;

Amlodipine EP
Impurity G

4-(2-Chlorophenyl)-1,4-dihydro-2,6impurities

43067-01-2

C₁₇H₁₈ClNO₄

335.78Dimethyl Ester;

Amlodipine
Impurity 29(93848-

impurities

C22H27ClN2O6

450.9293848-82-9

82-9)
Amlodipine
Impurity 27
Disodium

120289-11-4

C19H18ClNO7. 2(free Acid)Na

impurities

NA

C27H25ClN2O7

524.95

impurities

NA

C13H13NO4

247.25

impurities

NA

impurities

407.81 2 22.99

Salt(120289-11-4)
Amlodipine
Impurity 25
Amlodipine
Impurity 24
Amlodipine
Impurity 19

dimethyl-3,5-pyridinedicarboxylic Acid 3,5-

C26H29ClN2O7S 549.04

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nameAmlodipine
Impurity 6

category

cas_number

mol_formulamol_weightsynonym

impurities

3891-07-4

C10H9NO3

191.19(N-(2-Hydroxyethyl)phthalimide)
3,5-Pyridinedicarboxylic acid, 4-(2-Amlodipine
Aspartic Acid

impurities

400602-35-9

C24H29ClN2O9

524.96

Impurity

dicarboxyethyl)amino]ethoxy]methyl]-1,4d

Lamivudine
Impurity A

chlorophenyl)-2-[[2-[(1,2-(2R-cis)-5-(4-amino-2-oxo-1(2H)impurities

173829-09-9

C₈H₉N₃O₄S

243.24pyrimidinyl)-1,3-oxathiolane-2-carboxylic
Acid;
2,6-Bis[(2-aminoethoxy)methyl]-4-(2-Amlodipine EP
Impurity C Maleate

impurities

721958-74-3

C₂₂H₃₀ClN₃O₆

467.94

chlorophenyl)-1,4-dihydro-3,5pyridinedicarboxylic Acid 3-Ethyl 5-Methyl
Ester;(1S,3S,5S)-2-((R)-2-amino-2-

Saxagliptin Amide
Impurity

impurities

1496712-39-0

C18H23N3O2

313.4((1s,3R,5S,7S)-4-oxoadamantan-1yl)acetyl)-2-azabicyclo[3.1.0]hexane-3carbonitrile

Amlodipine EP
Impurity E
Maleate(diethyl
ester)

2-[(2-Aminoethoxy)methyl]-4-(2impurities

140171-65-9

C₂₁H₂₇ClN₂O₅422.9

chlorophenyl)-1,4-dihydro-6-methyl-3,5pyridinedicarboxylic Acid 3,5-Diethyl Ester;VIVAN社総販売店： オー・ジー株式会社
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nameLamotrigine EP
Impurity A
Dianisylglycerol

category

cas_number

mol_formulamol_weight

impurities

252186-78-0

C9H6Cl2N4O

257.08

impurities

16929-60-5

C17H20O5

304.34

Risperidone
Impurity E/6Methyl Risperidone

Risperidone
Desfluoro
Risperidone
Difluoro

3-Amino-6-(2,3-dichlorophenyl)-1,2,4tryriazin-5(2H)-one;
1,3-Bis(2-methoxyphenoxy)-2-propanol ;3-[2-4-(6-Fluoro-1,2-benzisoxazol-3-yl)-

impurities

1346602-28-5

C24H29FN4O2

424.51

1-piperidinyl]ethyl-6,7,8,9-tetrahydro-2,6dimethyl-4H-pyrido[1,2-a]pyrimidin-4-one;
3-[2-[4-(1,2-Benzisoxazol-3-yl)-1-

impurities

106266-09-5

C23H28N4O2

392.49piperidinyl]ethyl]-6,7,8,9-tetrahydro-2methyl-4H-pyrido[1,2-a]pyrimidin-4-one;

impurities

158697-67-7

C23H27F2N3O2

415.48Risperidone Difluoro Acetyl Impurity ; 4(2,4-Difluorobenzoyl)-N-acetylpiperidine
3-[2-[4-[(Z)-(2,4-

Risperidone ZOxime Impurity

synonym

impurities

132961-05-8

C23H28F2N4O2

430.49Difluorophenyl)(hydroxyimino)methyl]-1piperidinyl]ethyl]-6,7,8,9-tetrahydro-2methyl-4H-pyrido[1,2-a]pyrimidin-4-one;

Enalapril EP
Impurity A Maleate((S,S,R)-Enalapril
Maleate)impurities

76420-74-1

C20H28N2O5.
C4H4O4N-[(1S)-1-(Ethoxycarbonyl)-3376.45 116.07 phenylpropyl]-L-alanyl-L-proline (2Z)-2Butenedioate; Acapril; Acetensil;

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name
2-(2-Chloroethoxy)
ethanol

category

cas_number

mol_formula

impurities

5197-62-6

C4H9ClO2

mol_weight'124.57

synonym
Diglycol chlorohydrin; Ethanol, 2-(2chloroethoxy)-; Diglycol chlorhydrin;
N-[4-(4-Fluorophenyl)-6-(1-methylethyl)-

Rosuvastatin
dehydro Analog

5-[(1E)-2-[(2S,4R)-tetrahydro-4-hydroxyimpurities

1659301-59-3

C22H25FN3NaO5S

485.5

6-oxo-2H-pyran-2-yl]ethenyl]-2pyrimidinyl]-N-methylmethanesulfonamide;

Piperquine Impurity
1
Clopidogrel Related
CompoundA
Diclofenac Impurity
F

impurities

impurities

impurities

837-52-5

144750-42-5

560075-65-2

C13H14ClN3
C15H14ClNO2S ·HCl
C₁₄H₁₀Cl₃NO

247.73[7-Chloro-4-(Piperazinyl)quinoline](S)-(2-Chlorophenyl)-6,7-344.26dihydrothieno[3,2-c]pyridine-5(4H)-acetic
acid hydrochloride

314.592,6-Dichloro-N-(4-chlorophenyl)benzeneacetamide
1-[(1-Oxopentyl)amino]-N-[[2’-(2H-Irbesartan ImpurityA

impurities

748812-53-5

C₂₅H₃₀N₆O₂

446.54

tetrazol-5-yl)[1,1’-biphenyl]-4-yl]methyl]cyclopentanecarboxamideUSP Irbesartan
USP Related Compound;

Tenfovir Impurity B

impurities

4121-40-8

C₈H₉N₅175.199-(1-Propen-1-yl)-9H-purin-6-amine; 9(1-Propenyl)-9H-purin-6-amine;VIVAN社総販売店： オー・ジー株式会社
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nameFluconazole
Impurity D

category

cas_number

mol_formulamol_weight

impurities

81886-51-3

C₁₃H₁₃FN₆O

288.28synonymα-(4-Fluorophenyl)-α-(1H-1,2,4-triazol1-ylmethyl)-1H-1,2,4-Triazole-1-ethanol;(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-2Ethyl-3,4,10,13-tetrahydroxy-

Azithromycin
Impurity J

impurities

117693-41-1

C₃₀H₅₈N₂O₉590.79

3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6trideoxy-3-(dimethylamino)-β-D-xylohexopyranosyl]oxy]-1-oxa-6azacyclopentadecan-15-one;

Lamivudine
Impurity H
Clopidogrel Related
Compound B

Lamivudine (R)-S-Oxide; 4-Amino-1impurities

160552-54-5

C₈H₁₁N₃O₄S

245.26[(2R,3R,5S)-2-(hydroxymethyl)-3-oxido1,3-oxathiolan-5-yl]-2(1H)-pyrimidinone;(RS )-Methyl (2-chlorophenyl)-4,5-

impurities

144750-52-7

C₁₆H₁₇Cl₂NO₂S

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mol_formulamol_weightsynonym(3R,4S,5S,6R,7R,9R,11S,12R,13S,14R,E)14-ethyl-12,13-dihydroxy-4(((2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6dimethyltetrahydro-2H-pyran-2-yl)oxy)-6-Clarithromycin Impurity M

impurities

127182-43-8

748.94 (((2S,3R,4S,6R)-3-hydroxy-6-methyl-4-

C37H68N2O13(methylamino)tetrahydro-2H-pyran-2yl)oxy)-10-(hydroxyimino)-7-methoxy3,5,7,9,11,13hexamethyloxacyclotetradecan-2-one
Clarithromycin Impurity C

impurities

127253-06-9
C38H70N2O13

Clarithromycin Impurity G

impurities

Risperidone E -oxime

impurities

127182-44-9
691007-09-7

C39H72N2O13
C23H28F2N4O2

430.49Clarithromycin E-9-Oxime; Clarithromycin
762.96 (9E)-Oxime; 6-O-Methylerythromycin 9Oxime;
Clarithromycin EP impurity G;ClarithrE)-O776.99 Methyloxime; 6-O-Methylerythrthyloxime);
3-[2-[4-[(E)-(2,4Difluorophenyl)(hydroxyimino)methyl]-1piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl4H-pyrido[1,2-a]pyrimidin-4-one;(3R,5R,E)-7-(4-(4-Fluorophenyl)-6-

Rosuvastatin antiIsomer Calcium
Salt

impurities

1094100-06-7(acid)

isopropyl-2-(NC22H27FN3O6S

480.53methylmethylsulfonamido)pyridimidin-5yl)-3,5-dihydroxyhept-6-enoic
acid;Rosuvastatin (3R,5R)-Isomer Calcium

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namecategory

cas_number

mol_formulamol_weightsynonym